18
April
2023
|
09:26 AM
America/New_York

FDA Approves Expanded Age Group for Autism Spectrum Disorder Study

Summary

Carilion is one of 22 locations worldwide offering the study

Carilion is one of 22 locations worldwide offering patients access to The Tapestry Study, which is researching a potential new approach to treating Autism-related irritability. 

Now, children with autism spectrum disorder (ASD) ranging in age from 5-17 years old are eligible for screening to participate. Prior to the FDA age expansion, the study was for teenagers 13-17 years old.

The clinical trial is researching an experimental treatment designed to isolate certain gut-derived bacterial metabolites and reduce their ability to enter the bloodstream and reach the brain. The trial, which is based on increasing evidence of a link between gut bacteria and the brain, looks at the potential benefits, safety, and tolerability of a powder medication (AB-2004) in participants between the ages 5 to 17.

AB-2004 is a tasteless and odorless powder medication that is mixed with soft food three times a day. This study aims to assess whether lowering key gut bacterial metabolites levels can improve irritability in children with ASD. It also seeks to determine the most effective therapeutic dose.

Dr. Anita Kablinger is the primary investigator leading the research at Carilion.

“This study builds on research on the gut-brain connection," said Kablinger, “using a medication that interacts with certain bacteria in the gut in ways that reduce their ability to enter the bloodstream, thereby reducing their contributions to irritability.” 

The study requires eligible participants to meet the following requirements:

  • 5 to 17 years of age
  • Clinically diagnosed and documented ASD
  • Stable therapeutic regimen for at least 30 days prior to screening visit and for the duration of the study
  • Not currently using antipsychotic medications

So far worldwide since the study began, 39 participants have been enrolled. The study expects to wrap up enrollment by fall of this year.

Researchers are seeking participants now. For more information on the Tapestry Study visit CarilionClinic.org/AutismStudy. If you have questions, contact Clinical Research Coordinator Bryce Lewis (brlewis@carilionclinic.org or 540-494-8285).